PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk

This study is not yet open for participant recruitment.
Verified June 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01879189
First received: June 12, 2013
Last updated: June 26, 2013
Last verified: June 2013

June 12, 2013
June 26, 2013
September 2013
December 2014   (final data collection date for primary outcome measure)
Mammography Use Correlated to Personal Risk of Breast Cancer [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]
Medical charts of women in both the intervention and control groups of the study will be analyzed to determine if these women initiated breast cancer screening (mammography) correlated to their personal risk of breast cancer as displayed by the decision aid.
Same as current
Complete list of historical versions of study NCT01879189 on ClinicalTrials.gov Archive Site
Worry, Behavior, Numeracy, Knowledge, Satisfaction [ Time Frame: 6 weeks post-intervention ] [ Designated as safety issue: No ]
Six weeks after a women's appointment with their primary care or OB/GYN provider, they will receive a post-intervention survey which will assess knowledge, worry, satisfaction, numeracy, behavior, etc.
Same as current
Not Provided
Not Provided
 
PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk
PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk Using a Web-based Breast Cancer Screening Decision Aid Tool

In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool will be pilot tested, and then implemented and tested in nine primary care and OB/GYN practices within the University of Pennsylvania Health System.

In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool incorporates questions about a women's personal history of breast cancer and compares her to the average women her age in terms of breast cancer risk. The tool helps the women to understand the benefits and risks of breast cancer screening. This tool will be pilot tested using SSI to help develop the final version of the decision aid tool. The decision aid tool will then be implemented and tested in nine general internal medicine, family medicine, and OB/GYN practices within the University of Pennsylvania Health System.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Breast Cancer
Behavioral: Breast Cancer Screening Decision Aid
The intervention will include access to the personal decision aid tool for patients in the intervention arm of the study, determined by the randomized physician schedule and the patient's appointment time.
  • Experimental: Decision Aid
    Those in the decision aid arm of the study will be given access to the breast cancer screening decision aid.
    Intervention: Behavioral: Breast Cancer Screening Decision Aid
  • No Intervention: Standard of Care
    Those in the standard of care arm will not be given access to the decision aid.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1500
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women ages 39-48
  • Patient of one of the nine primary care or OB/GYN practices that are participating in the study
  • Must have had an appointment at one of these locations in the past 24 months
  • Must have an appointment during the study period
  • Woman has not yet initiated breast cancer screening (no prior mammogram)
  • No history of breast cancer

Exclusion Criteria:

  • Prior diagnosis of breast cancer
  • Major comorbidity that substantially affects their 10 year mortality
  • Non-English speaker
Female
39 Years to 48 Years
Yes
Not Provided
United States
 
NCT01879189
81670
No
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Marilyn Schapira, MD University of Pennsylvania
University of Pennsylvania
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP